ARVIS Surgical Navigation System Recall Issued by Kico Knee Innovation
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Kico Knee Innovation Company is recalling 78 units of the ARVIS Surgical Navigation System Gen 2 (model IN-29200) due to an internal sensor issue causing the displayed image to appear tilted.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on September 9, 2026 and geographically references United States. The FDA classifies this as a Class II recall, with the stated reason "Due to an internal sensor issue, image displayed with eyepiece may appear tilted relative to the eyepiece housing", distributed consignee consignee number region device quantity rfk medical ce102 richmond va in-29200, arvis surgical navigation 1 valor medical ce118 san antonio tx in-29200, arvis surgical navigation 2 joint ventures medical ce121 oshkosh wi in-29200, arvis surgical navigation 1 castle medical ce122 waterloo ia in-29200, arvis surgical navigation 6 great lakes medical gl108 naperville il in-29200, arvis surgical navigation 2 certus medical gl112 indianapolis in in-29200, arvis surgical navigation 5 i&s medical gl113 louisville ky in-29200, arvis surgical navigation 2 procore medical ma102 piedmont sc in-29200, arvis surgical navigation 1 fox medtech mw001 englewood co in-29200, arvis surgical navigation 2 medsource ne131 tiverton ri in-29200, arvis surgical navigation 4 implant medical sales ne190 hicksville ny in-29200, arvis surgical navigation 2 kinetic medicine nw105 omaha ne in-29200, arvis surgical navigation 4 calsurg nw115 santa barbara ca in-29200, arvis surgical navigation 4 midwest medical resources sc181 overland park ks in-29200, arvis surgical navigation 3 ortho & surgical solutions se175 guaynabo pr in-29200, arvis surgical navigation 3 joint medical solutions se180 birmingham al in-29200, arvis surgical navigation 4 flt orthopedics se216 tampa fl in-29200, arvis surgical navigation 6 mac medical w180 gilbert az in-29200, arvis surgical navigation 1 cp ortho w214 honolulu hi in-29200, arvis surgical navigation 1 unified orthopedics w223 riverside ca in-29200, arvis surgical navigation 18 movement medical w225 seattle wa in-29200, arvis surgical navigation 6 total number of devices in the field 78. FDA recall classes run from I (reasonable probability of serious harm) to III (unlikely to cause harm), so the class number is the fastest way to gauge severity here. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Before acting, the primary agency source is available to check alongside this summary. Its related labels are recall, product-safety, fda, Devices.
What Happened
Kico Knee Innovation Company initiated a voluntary recall of the ARVIS Surgical Navigation System Gen 2 because of an internal sensor issue where the image displayed with the eyepiece may appear tilted relative to the eyepiece housing.
Which Products Are Affected
The recall affects 78 units of the Brand Name: Kico Knee Innovation, Product Name: ARVIS SURGICAL NAVIGATION SYSTEM GEN 2, Model/Catalog Number: IN-29200. Affected software versions include ARVIS Hip and Knee Gap Balance Software v3.3.2 (IN-28200) and ARVIS Shoulder Software v2.0.3 (IN-23630). The devices were distributed to consignees across multiple U.S. states and territories including VA, TX, WI, IA, IL, IN, KY, SC, CO, RI, NY, NE, CA, KS, PR, AL, FL, AZ, and HI. Lot codes and serial numbers are listed in the recall details. Recall number: Z-2957-2026. Classification: Class II.
What You Should Do
Consumers and healthcare facilities should follow instructions provided in the firm's notification letter. Contact Kico Knee Innovation Company for further guidance on the affected devices.
Why This Matters
The ARVIS system is a computer-controlled navigation system used in orthopedic surgeries such as knee and hip arthroplasty to assist with implant positioning and alignment.
Source
FDA recall Z-2957-2026 (event ID 99372).
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Cardinal Health Presource Packs Recall Over CliniClean Pericare Wipes Contamination
FDA · September 14, 2026
Diagnostica Stago STA Staclot Protein S Recall Over QC Drift in Lot 273074
FDA · September 14, 2026
AVID Medical Halyard Convenience Kits Recall Over Endotoxin Variability in Neurological Sponges
FDA · September 14, 2026
Elsewhere in the country: similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,332 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to September 9, 2026.
What People Ask
Common questions about this FDA recall.